Diffusion Magnetic Resonance Imaging in Mamographically Detected Asymmetric Densities
Role of Diffusion Magnetic Resonance Imaging in Assessment of Mammographically Detected Asymmetric Densities
1 other identifier
observational
50
0 countries
N/A
Brief Summary
The aim of the study is to identify the role of diffusion weighted MRI in the assessment of the clinical significance and outcomes of asymmetric breast densities identified on mammograms, and to identify the inconclusive mammographic findings most frequently associated with occult breast carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2018
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 30, 2018
October 1, 2018
7 months
October 3, 2018
October 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of diffusion MRI finding with the pathology of the specimens
Analysis of diffusion weighted images and ADC values to defferntiate different pathologies causing asymmetric densities in routine screening or diagnostic mammography
Baseline
Interventions
Diffusion weighted sequence of MRI
Eligibility Criteria
sample size was calculated using EpiInfo7statcalc. Prog. With the following input population size: 120 expected frequency: 6% confidence limits: 5% design effect: 1.0 clusters: 1 The sample size was 50 cases at 95%confidence level.
You may qualify if:
- All patients presented with asymmetric breast densities, seen on screening or diagnostic mammograms.
You may not qualify if:
- Patients with cardiac pacemakers.
- Patients with brain aneurysm clips.
- Patients with cochlear implants.
- Patients with vascular stents.
- Claustrophobic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 4, 2018
Study Start
December 1, 2018
Primary Completion
July 1, 2019
Study Completion
October 1, 2019
Last Updated
October 30, 2018
Record last verified: 2018-10